1: Annotated Primary References

Angell M. Is Academic Medicine for Sale? N Engl J Med 2000; 342(20): 1516 - 1518.
-- Academic medicine has become seriously intertwined with the pharmaceutical and biotechnology industries. In addition, academic institutions have entered into partnerships with drug companies to create research centers. Stronger conflict-of-interest policies are needed, and rules regarding conflicts of commitment should be enforced. Certain financial ties, such as equity interests, should be prohibited altogether. The authors believe that "the incentives of the marketplace should not become woven into the fabric of academic medicine."

Bodenheimer T. Uneasy Alliance -- Clinical Investigators and the Pharmaceutical Industry. N Engl J Med 2000; 342(20): 1539-1544.
-- Without industry funding, important advances in disease prevention and treatment would have been lessened. Companies translate medical advances into treatments for patients, but when results are negative for a company, conflicts may develop. Trials conducted in the commercial sector, such as those by contract-research organizations and site-management organizations, have shifted clinical research into the commercial research networks. In a series of interviews with researchers and pharmaceutical executives, the industry-investigator relationship is analyzed, and includes the topics of trial design, data analysis, publishing results, and the control over publication and authorship.

Cho MK, Billings P. Conflict of Interest and Institutional Review Boards. J Investig Med 1997; 45(4): 154-159.
-- Recent ethically questionable studies have necessitated the examination of the role of the IRB. The IRB was designed to oversee the protection of the rights and welfare of human subjects. Both individual and institutional conflicts of interest exist for the IRBs. The authors provide the following suggestions for managing these conflicts: using IRBs that are independent from an institution; increasing community representation and the diversity of professionals that serve on IRBs; increasing accountability through the disclosure of conflicts or financial ties, both individual and institutional; and acknowledging the burden and insufficient resources of IRBs. They conclude that public trust is best maintained by protecting human subjects and avoiding conflicts.

Cho MK, Shohara R, Schissel A, Rennie D. Policies on Faculty Conflicts of Interest at US Universities. JAMA 2000; 284(17): 2203-2208.
-- Evidence exists that financial considerations bias the research record despite federal regulations covering faculty conflicts of interest in federally funded research. This study, a cross-sectional survey and content analysis conducted from August 1998 to February 2000, shows a wide range of approaches to the management of policies concerning faculty conflicts of interest from biomedical institutions in the United States. The authors conclude that this may cause "unnecessary confusion among potential industrial partners or competition among universities for corporate sponsorship that could erode academic standards." Institutions should develop clear and specific policies on conflicts of interest.

DeAngelis CD. Conflict of Interest and the Public Trust [Editorial]. JAMA 2002; 284(7): 2237.
-- "When an investigator has a financial interest in or funding by a company with activities related to his or her research, the research is lower in quality, more likely to favor the sponsorās product, less likely to be published, and more likely to have delayed publication." Safeguards must be developed by institutions to lessen these negative effects. All institutions that accept private funds must develop conflict-of-interest policies for disclosure and oversight; they must continuously monitor the relationships between their faculty and sponsoring companies. "Without [public] trust, research is doomed."

Friedman PJ. The Impact of Conflict of Interest on Trust in Science. Sci Eng Ethics 2002; 8(3): 413-420.
-- Conflicts of interest have an erosive effect on trust in science, damaging the attitude of the public toward scientists and their research and also weakening the trusting interdependence of scientists. Disclosure is recognized as the key tool for management of conflicts, but rules with sanctions must be improved, new techniques for avoidance of financial conflicts by alternative funding of evaluative research must be sought, and there must be new thinking about institutional conflicts of interest. The research professionās educational role is important, and both the public and research professionals of all ages would benefit from greater understanding of how science should work and does work.

Johns MM, Barnes M, Florencio PS. Restoring Balance to Industry-Academia Relationships in an Era of Institutional Financial Conflicts of Interest: Promoting Research While Maintaining Trust. JAMA; 289(6); 741-746.
-- Institutions and institutional decision-makers should fully disclose industry-related financial interests and relationships. Without legitimate justification for such interests, individuals should divest themselves from these interests or recuse themselves from responsibility for research oversight. Management of institutional partnerships might also entail the physical separation of certain facilities; the placement of restrictions on information shared between investment and research staffs; and the provisions of oversight by independent review panels made up of people who have expertise in intellectual property, finance, and research but who are not financially or otherwise dependent on the institution. It is possible to restore balance to industry-academia relationships, thereby promoting progress while maintaining public trust in research.

Martin JB, Reynolds TP. Academic-Industrial Relationships: Opportunities and Pitfalls. Sci Eng Ethics 2002; 8(3): 443-454.
-- Over the past 50 years, academic-industrial collaborations and technology transfer have played an increasingly prominent role in the biomedical sciences. These relationships can speed the delivery of innovative drugs and medical technologies to clinical practice, creating important public-health benefits as well as income for universities and their faculties. At the same time, such relationships raise ethical concerns, particularly when research involves human subjects in clinical trials. Lapses in oversight of industry-sponsored clinical trials at universities, and especially patient deaths in a number of trials, have brought these issues into the public spotlight and have led the federal government to intensify its oversight of clinical research.

Morin K, Rakatansky H, Riddick FA Jr., Morse LJ, O'Bannon JM 3rd, Goldrich MS, et al. Managing Conflicts of Interest in the Conduct of Clinical Trials. JAMA 2002; 287(1): 78-84.
-- The interaction between medical research and for-profit corporations has expanded considerably in recent years. A renewed commitment to the application of high ethical standards is essential to ensure that societal trust in research is not eroded, that subjects enrolled in trials do not become merely a means to an end, and that medical research is efficiently translated into clinical advances that will benefit future patients. This article focuses on the analysis of conflicts of interest in the conduct of clinical trials in both academic and community-based settings. It discusses how the roles of research scientists and clinical practitioners differ, and stresses the importance of ensuring that participants' consent to enroll in clinical trials is not the result of confusion about the goals of an experimental treatment that may resemble clinical care. The article also discusses the potential conflicts of interest that can arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials. This article emphasizes that, in order to preserve the integrity of research and to protect the welfare of human subjects who enroll in trials, physicians should have adequate training in the conduct of research and should be familiar with the ethics of research. Finally, the article addresses disclosure of financial incentives and related funding issues.

Shenk D. Money + Science = Ethics Problems on Campus. The Nation, 22 March 1999.
-- There has been a radical shift in the funding of American science, and this shift has caused concern among university ethicists. There has been a fivefold increase in the amount of private capital spent on university-based science and engineering research between 1977 and 1997. These new alliances have generated a lot of profit, which has both economic and health implications for American consumers. Because universities exist to do research that benefits mankind -- while the goal of companies is to make a profit -- there is concern that the integrity of science is being jeopardized by this different value system. A survey of sponsored academic research found that 58% of companies required investigators to withhold results for more than six months. This secrecy cost dollars and lives. The history of research funding in the US is reviewed, along with a discussion of the Synthroid/Betty Dong controversy.